Prevention of Phantom Limb Pain After Transtibial Amputation

Description

Phantom limb pain following amputation is a major problem. Current evidence how to best prevent phantom limb pain is equivocal because previous trials have included small numbers of patients, and tested heterogeneous patient collectives. There is some evidence that optimized perioperative pain control is effective in preventing phantom limb pain, but the potential added role of regional anesthesia has not been defined. Objective: The Aim of this study is to test the hypothesis that sciatic nerve block decreases the point prevalence of phantom limb pain 12 months after transtibial amputation for peripheral vascular disease compared to optimized intravenous pain therapy. Study design: Randomized, prospective, double-blind (patient, physician, statistician) clinical trial. All patients will receive standard optimized intravenous anesthesia and analgesia (opiate patient-controlled analgesia (PCA), intravenous ketamine). Patients in the intervention group will receive additional infusion of local anesthetic via a sciatic nerve catheter placed under ultrasound guidance. Main outcome of this study: Point prevalence of chronic phantom limb pain after 12 months.

Study Start Date

August 2013

Estimated Completion Date

October 2016

Interventions

  • Procedure: Sciatic name block

Specialties

  • Neurology: Pain Medicine
  • Pain Management: Surgery

MeSH Terms

  • Phantom Limb
  • Sciatic name block

Study ID

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) -- PLATA

Status

Unknown

Trial ID

NCT01626755

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

400

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Inclusion Criteria

  • patients undergoing elective transtibial amputation for peripheral vascular disease
  • age over 18 years
  • American Society of Anaesthesiology status II to IV

Exclusion Criteria

  • contraindication to peripheral regional anesthesia
  • psychiatric disease
  • pregnancy or breastfeeding status
  • amputation for tumour surgery
  • traumatic amputation
  • inability to give written and informed consent.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Massachusetts General Hospital Dept of Anesthesiology Perioperative and Pain Medicine - Boston, Massachusetts 2.6 miles None None None

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